Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071791
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/15/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/17/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/09/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/04/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/04/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/10/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/24/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/28/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |